INDICATIONS AND USAGE（适应症）

Class 3 Beta-Thalassemia

TEPADINA is indicated to reduce the risk of graft rejection when used in conjunction with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT) for pediatric patients with class 3 beta-thalassemia.

Adenocarcinoma of the Breast or Ovary

TEPADINA is indicated for treatment of adenocarcinoma of the breast or ovary.

Malignant Effusions

TEPADINA is indicated for controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities.

Superficial Papillary Carcinoma of the Urinary Bladder

TEPADINA is indicated for treatment of superficial papillary carcinoma of the urinary bladder.

DOSAGE（服用剂量）

The recommended dose of TEPADINA in pediatric patients is two administrations of 5 mg/kg given intravenously approximately 12 hours apart on Day -6 before allogeneic HSCT in conjunction with high-dose busulfan and cyclophosphamide. See Prescribing Information for cyclophosphamide and busulfan for information on these drugs. The recommended dose of TEPADINA in pediatric patients is two administrations of 5 mg/kg given intravenously approximately 12 hours apart on Day -6 before allogeneic HSCT in conjunction with high-dose busulfan and cyclophosphamide.

Infuse TEPADINA via a central venous catheter over 3 hours using an infusion set equipped with a 0.2 micron in-line filter. Prior to and following each infusion, flush the catheter with approximately 5 ml sodium chloride 0.9% solution for injection. Infuse TEPADINA via a central venous catheter over 3 hours using an infusion set equipped with a 0.2 micron in-line filter. Prior to and following each infusion, flush the catheter with approximately 5 ml sodium chloride 0.9% solution for injection.

TEPADINA is excreted through the skin of patients receiving high-dose therapy. Take precautions to prevent skin toxicity. TEPADINA is excreted through the skin of patients receiving high-dose therapy. Take precautions to prevent skin toxicity.

Adenocarcinoma of the Breast or Ovary​

The recommended dose of TEPADINA for treatment of adenocarcinoma of the breast or ovary is 0.3 to 0.4 mg/kg intravenously. Doses should be given at 1 to 4 week intervals. Initially the higher dose in the given range is commonly administered. The maintenance dose should be adjusted weekly on the basis of pretreatment control blood counts and subsequent blood counts. Maintenance doses should not be administered more frequently than weekly. The recommended dose of TEPADINA for treatment of adenocarcinoma of the breast or ovary is 0.3 to 0.4 mg/kg intravenously. Doses should be given at 1 to 4 week intervals. Initially the higher dose in the given range is commonly administered. The maintenance dose should be adjusted weekly on the basis of pretreatment control blood counts and subsequent blood counts. Maintenance doses should not be administered more frequently than weekly.

Malignant Effusions

The recommended dose of TEPADINA for treatment of malignant effusions is 0.6 to 0.8 mg/kg intracavitary. Administration is usually effected through the same tubing which is used to remove the fluid from the cavity involved. Doses should be given at 1 to 4 week intervals. Initially the higher dose in the given range is commonly administered. The maintenance dose should be adjusted weekly on the basis of pretreatment control blood counts and subsequent blood counts. Maintenance doses should not be administered more frequently than weekly.The recommended dose of TEPADINA for treatment of malignant effusions is 0.6 to 0.8 mg/kg intracavitary. Administration is usually effected through the same tubing which is used to remove the fluid from the cavity involved. Doses should be given at 1 to 4 week intervals. Initially the higher dose in the given range is commonly administered. The maintenance dose should be adjusted weekly on the basis of pretreatment control blood counts and subsequent blood counts. Maintenance doses should not be administered more frequently than weekly.

Superficial Papillary Carcinoma of the Urinary Bladder​

The recommended dose of TEPADINA for treatment of superficial papillary carcinoma of the urinary bladder is 60 mg in 30 to 60 mL of Sodium Chloride Injection into the bladder by catheter. The solution should be retained for 2 hours. If the patient finds it impossible to retain 60 mL for 2 hours, the dose may be given in a volume of 30 mL. The patient may be repositioned every 15 minutes for maximum area contact. The usual course of treatment is once a week for 4 weeks. The course may be repeated if necessary, but second and third courses must be given with caution since bone-marrow depression may be increased.The recommended dose of TEPADINA for treatment of superficial papillary carcinoma of the urinary bladder is 60 mg in 30 to 60 mL of Sodium Chloride Injection into the bladder by catheter. The solution should be retained for 2 hours. If the patient finds it impossible to retain 60 mL for 2 hours, the dose may be given in a volume of 30 mL. The patient may be repositioned every 15 minutes for maximum area contact. The usual course of treatment is once a week for 4 weeks. The course may be repeated if necessary, but second and third courses must be given with caution since bone-marrow depression may be increased.

ADVERSE REACTIONS（不良反应）

Myelosuppression

Infection

Hypersensitivity

Cutaneous Toxicity

Hepatic Veno-Occlusive Disease

Central Nervous System Toxicity

Carcinogenicity

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/559e353c-2dc0-16ba-e054-00144ff8d46c/spl-doc?hl=Tepadina

tepadinainformation